Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00309699 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
A Phase 3 study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- Completed
- Registry status
- Phase 3
- Development phase
- 493
- Enrollment target
NCT00309699 is a Phase 3 study that has completed, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. The registered enrollment target is 493 participants.
The verdict
NCT00309699, a Phase 3 study, has completed, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 493 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of paliperidone ER on global functioning, and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks.
Interventions
- DRUG Placebo
- DRUG Quetiapine
- DRUG Paliperidone ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 493 participants |
| Start Date | 2006-04 |
| Est. Completion | 2007-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00309699
The ClinicalTrials.gov registry entry for NCT00309699 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 493 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00309699 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00309699 about?
NCT00309699 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder". The purpose of this study is to evaluate the effectiveness and safety of flexible-doses paliperidone ER (3 to 12 mg as needed) compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode. This study will also evaluate the effects of pal...
What is the current status of trial NCT00309699?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 493 participants. The study started on 2006-04. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00309699?
The interventions under investigation include: Placebo (DRUG), Quetiapine (DRUG), Paliperidone ER (DRUG).
Who is sponsoring clinical trial NCT00309699?
This trial is sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which has 102 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.